Germany looks set to introduce new measures to curb pharmaceutical spending, including higher mandatory rebates for outpatient drugs and combination products. It will also lower the threshold at which orphan drugs must undergo a benefit assessment.
A new German bill on financing health insurance has outlined plans to cut pharmaceutical spending by lowering the threshold at which orphans must undergo more rigorous benefit assessments, increasing mandatory rebates and introducing a cap on spending on future drug indications.
Some of the measures could see some companies opting out of the German market, warns Alexander Natz, secretary general of...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
